Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT07247318
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years;
* PaO₂/FiO₂ ≤ 300 mmHg or SpO₂/FiO₂ ≤ 315 (with SpO₂ ≤ 97%);
* Requiring one of the following respiratory supports:
1. Noninvasive positive pressure ventilation with PEEP ≥ 5 cmH₂O, or
2. High-flow nasal oxygen therapy with a flow rate ≥ 30 L/min, or
3. Conventional oxygen therapy with an oxygen flow ≥ 10 L/min, where FiO₂ is calculated using the formula: FiO₂ = 0.21 + (oxygen flow rate × 0.03).
Exclusion Criteria:
* Received CPAP or NIV for more than 24 hours prior to screening.
* Received invasive mechanical ventilation during the current hospitalization.
* Presence of chronic underlying pulmonary disease, or PaCO₂ ≥ 45 mmHg.
* Presence of cardiogenic pulmonary edema.
* Hemodynamic instability, defined as systolic blood pressure \< 90 mmHg or norepinephrine-equivalent dose \> 0.3 µg/kg/min.
* Impaired consciousness (GCS ≤ 12).
* Patients requiring urgent intubation, including those with respiratory or cardiac arrest, apnea with loss of consciousness or gasping, or severe hypoxemia (defined as SpO₂ \< 90% despite 100% oxygen).
* Contraindications to NIV: cardiac or respiratory arrest, coma, untreated pneumothorax, uncontrollable vomiting, upper airway obstruction, hematemesis or severe facial trauma, or thoracic/abdominal surgery within the past 7 days.
* Contraindications to EIT: implanted cardiac pacemaker, unstable spinal injury or fracture, or open chest trauma.
* Refusal of endotracheal intubation.
* Pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07247318
Study Brief:
Protocol Section:
NCT07247318